CanadaSoft‑Vu and Accu‑Vu 4 FR angiographic catheters from AngioDynamics are affected; the notice lists specific model/catalogue numbers (for example 10714009, 10714016, 13709804, H787107100315, 10732301, 10714001, 10707103, 10714002, 10714018, 10714017, 10714021, 10714014, 10734301) and lot/serial numbers described as “more than 10 numbers.” The devices were recalled because a molded hub non‑conformance may prevent the appropriately sized guidewire from passing through the catheter hub; multiple complaints were received but no patient injuries or Canadian events were reported, and owners should contact the manufacturer for additional information.
What's being recalled
Companies: AngioDynamics, Inc., 603 Queensbury Avenue, Queensbury, New York, United States, 12804.
How to identify it
Affected products: Soft-Vu Angiographic Catheters: Berentstein: (Braided & Non); Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 10714009
Affected products: Soft-Vu Angiographic Catheters: Berentstein: (Braided & Non); Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 10714016
Affected products: Accu-Vu Sizing Catheter - Pigtail Flush; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 13709804
Affected products: Soft-Vu Angigraphic Catheters: Shepherd Hook (Braided & Non); Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: H787107100315
Affected products: Soft-Vu Angiographic Catheters - Omni Flush; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 10732301
Affected products: Soft-Vu Angiographic Catheters - Omni Flush; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 10714001
Affected products: Soft-Vu Angiographic Flush Catheters: Pigtail; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 10707103
Affected products: Soft-Vu Angiographic Flush Catheters: Pigtail; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 10714002
Affected products: Soft-Vu Angiographic Selective Catheters: Cobra (Braided & Non); Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 10714018
Affected products: Soft-Vu Angiographic Selective Catheters: Cobra (Braided & Non); Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 10714017
Affected products: Soft-Vu Angiographic Catheters - Kumpe; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 10714021
Affected products: Soft-Vu Angiographic Catheters - Kumpe; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 10714014
Affected products: Soft-Vu Angiographic Catheters - Kumpe; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 10734301
The hazard
AngioDynamics, Inc., is conducting a voluntary medical device field safety corrective action or recall to the end-user level based on the non-conformance of a molded hub in specific models and lots of Soft-Vu and Accu-Vu 4 fr angiographic catheters. The affected Soft-Vu and Accu-Vu 4 fr angiographic catheters being recalled (removed) contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
AngioDynamics has become aware of the non-conformance by way of multiple complaints associated with the affected angiographic catheter devices; however, there have been no complaints or events that occurred in Canada. There are no reports of patient injury as a result of this issue.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)
United States